cleaning of capsule bulk packing machine

1.0 OBJECTIVE 
To ensure that the cleaning procedure removes residues to extent of compliance with predetermined acceptance level.

2.0 SCOPE
This protocol applicable for cleaning of Capsule Bulk Packing Machine.

3.0 RESPONSIBILITY
Q.C. Officer ,
Q.C. In-charge .

4.0 PROCEDURE

 

Clean as per SOP no :——

a) Sampling Plan : 1. Sample from first rinse.
2. Sample from Second rinse.
3. Sample from final rinse of purified water.
4. Swab Test ( 2 inch x 2 inch )

b) Sampling Point : 1. Hopper
2. Vibrating Plate.
3. Discharge chute
4. Lid.

c) Test / Method : 1.Inspect visually for the absence of previous
product in the equipment.
2. Determine absence of detergent in final rinse.
3. Determine concentration of active ingredient of
previous product in the rinse.

d) Acceptance : 1. Detergent should not be indentifiable by frothing Criteria test
2. Concentration should not be detectable by
Annexure – 1

e) Experiment :

f) Recommendation : 1. If concentration is not detectable then cleaning
stands validation valid.

 

 

APPROVAL :

The undersigned signatures certify that the validation programme and acceptance criteria set forth in this protocol are sufficient to establish cleaning validation .

 

 

 

Approved by                                                                                                                                  Date: